1stOncology™: Cancer Intelligence Service – Page 14348 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Atreca Reports Second Quarter 2019 Financial Results and Recent Corporate Developments

On August 13, 2019 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported financial results for the second quarter ended June 30, 2019, and provided an overview of Atreca’s recent developments (Press release, Atreca, AUG 13, 2019, View Source [SID1234538759]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"The second quarter of 2019 was a highly productive period for Atreca, highlighted by the completion of our successful initial public offering, which further strengthens our ability to execute on the promise of our differentiated technology platform drawn from a deep understanding of the human immune response," said John Orwin, Chief Executive Officer. "We believe our lead product candidate, ATRC-101, represents an exciting and novel approach to cancer therapy with the potential to drive better outcomes for patients across a variety of solid tumors. We look forward to submitting the Investigational New Drug (IND) application for ATRC-101 later this year and initiating a Phase 1b clinical trial in patients with solid tumors in early 2020."

Recent Developments and Highlights

·In June 2019, Atreca successfully completed its initial public offering, raising $130.8 million in net proceeds.

·In July 2019, Atreca further strengthened its management team with the appointments of Lisa L. Decker, Ph.D., as Chief Business Officer and Courtney J. Phillips as General Counsel.

Upcoming Milestones

·Atreca anticipates filing an IND application with the U.S. Food and Drug Administration for ATRC-101 in late 2019 and initiating a Phase 1b clinical trial in patients with solid tumors in early 2020.

Second Quarter 2019 Financial Results

·As of June 30, 2019, cash and cash equivalents and short-term investments totaled $219.7 million. This includes net proceeds of approximately $130.8 million from Atreca’s June 2019 initial public offering of common stock, after deducting the underwriting discounts and commissions and expenses of the offering.

·Research and development expenses for the three months ended June 30, 2019 were $15.9 million, including non-cash share-based compensation expense of $752,000.

·General and administrative expenses for the three months ended June 30, 2019 were $3.5 million, including non-cash share-based compensation expense of $607,000.

·Atreca reported a net loss of $17.9 million, or basic and diluted net loss per share attributable to common stockholders of $3.67, for the three months ended June 30, 2019.

Aeterna Zentaris Reports Second Quarter 2019 Financial and Operating Results

On August 13, 2019 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) reported its financial and operating results for the second quarter ended June 30, 2019 (Press release, AEterna Zentaris, AUG 13, 2019, View Source [SID1234538757]).

All Amounts are in U.S. Dollars

Highlights

On June 6, 2019, the Company announced that it was reducing the size of its German workforce and operations to more closely reflect the Company’s ongoing commercial activities in Frankfurt. This restructuring affects 8 employees in Frankfurt, Germany and resulted in $773,000 of severance costs that are expected to be paid by January 31, 2020.

Net income for the second quarter of 2019 was $0.2 million as compared to a net loss of $2.6 million for the same period in 2018. Net loss for the six-months ended June 30, 2019 was $4.7 million as compared to net income of $11.8 million for the same period in 2018.

In the first six months of 2019, the Company earned $21,000 from the license of Macrilen (macimorelin) as gross sales in the U.S. continue to disappoint. Novo Nordisk has advised that Macrilen (macimorelin) has been successfully integrated into their patient and provider support hub as they work to gain broader product coverage with payers and specialty pharmacies. We continue to work with Novo Nordisk on addressing the disappointing U.S. commercial execution and results to date.

The initial phase of the macimorelin pediatric development program (the dose ranging study), continued to progress with the first one-third of subjects having completed the protocol, all in accordance with our expected timeline.
Summary of Second Quarter Results and Year-to-date Second Quarter Results

For the three-month period ended June 30, 2019, we reported a consolidated net income of $0.2 million, or $0.01 income per common share (basic), as compared with a consolidated net loss of $2.6 million, or $0.16 loss per common share, for the three-month period ended June 30, 2018. The $2.8 million improvement in net results is primarily from a gain in fair value of warrant liability of $4.1 million, offset by a loss in exchange rates of $0.7 million, an increase in operating expenses of $0.3 million and $0.2 million movement in tax recovery.

For the six-month period ended June 30, 2019, we reported a consolidated net loss of $4.7 million, or $0.28 loss per common share, as compared with a consolidated net income of $11.8 million, or $0.72 income per common share (basic), for the six-month period ended June 30, 2018. The $16.5 million decline in net results is primarily from a reduction of $24.5 million in gross income and $0.6 million decrease in net finance income, offset by a reduction of tax expense of $6.6 million and operating expenses of $1.9 million.

Condensed Interim Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the condensed interim consolidated financial statements as at June 30, 2019 and for the three-month and six-month periods ending June 30, 2019 and 2018 and management’s discussion and analysis of financial condition and results of operations for the three-month and six-month periods ending June 30, 2019, will be found at www.zentaris.com in the "Investors" section and at the Company’s profile at www.sedar.com and www.sec.gov.

The tables below set out summary consolidated financial information for the periods indicated. These tables should be read together with the condensed interim consolidated financial statements as at June 30, 2019 and for the three-month and six-month periods ending June 30, 2019 and 2018 and management’s discussion and analysis of financial condition and results of operations for the three-month and six-month periods ending June 30, 2019, which contain important information relating to the Company. The results of operations for interim periods are not necessarily indicative of the results to be expected for a full year or any future period. The information presented herein does not contain disclosures required by IFRS for consolidated financial statements and should be read in conjunction with the Company’s audited annual consolidated financial statements for the year ended December 31, 2018.

KemPharm Reports Second Quarter 2019 Results

On August 13, 2019 KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, reported its corporate and financial results for the quarter ended June 30, 2019 (Press release, KemPharm, AUG 13, 2019, View Source [SID1234538734]).

"Our highest priority at KemPharm has been securing a licensing agreement that maximizes the value of KP415 and KP484. This licensing process has taken longer than expected as we have had several late entrants. Yet, we believe we are in the final phase of this process and remain optimistic about reaching a successful conclusion as soon as possible," said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. "Looking ahead, once this partnership is finalized, we will focus our full attention in conjunction with our partner to finalize the NDA for KP415, which we believe could likely be filed prior to year-end."

"Additionally, we continue to work diligently with KVK Tech to prepare for the commercial launch of APADAZ, which remains on track for the second half of 2019," added Dr. Mickle. "Together with KVK, both the commercial outreach and manufacturing processes are moving forward in parallel. We look forward to reporting our progress in the coming months."

Q2 2019 Financial Results:

For the quarter ended June 30, 2019, KemPharm’s reported net loss was $9.3 million, or $0.33 per basic and diluted share, compared to a net loss of $10.0 million, or $0.65 per basic share and $0.91 per diluted share for the same period in 2018. Net loss for Q2 2019 was driven primarily by a loss from operations of $7.8 million, and net interest expense and other items of $1.5 million. The loss from operations for Q2 2019 decreased by $6.1 million compared to a loss from operations of $13.9 million in Q2 2018, which was primarily due to decreases of $5.7 million in research and development expenses and $0.4 million in general and administrative expenses, respectively.

As of June 30, 2019, total cash, which is comprised of cash, cash equivalents and restricted cash, was $7.8 million, which was a decrease of $6.2 million as compared to March 31, 2019.

"During the quarter, we took a number of steps to reduce our operating, general and administrative expenses, including an approximate 30% reduction in workforce compared to the end of Q1 2019, with the goal of reducing our cash burn rate while maintaining our research and development capabilities to support our ongoing work with KP415 and KP484, as well as remaining positioned to support the ultimate commercial partner once that process has been completed. Additionally, as the NDA filing approaches, we expect to see the expenditures related to KP415 R&D continue to reduce substantially," concluded Dr. Mickle.

Innovus Pharma Reports Quarterly Revenue for the Second Quarter 2019 of $6.8 million, a 27.7% Increase from Prior Quarter

On August 13, 2019 Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the "Company") (OTCQB: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women’s health and respiratory diseases, reported results for the second quarter ended June 30, 2019 (Press release, Innovus Pharmaceuticals, AUG 13, 2019, View Source [SID1234538733]).

Financial highlights for the second quarter ended June 30, 2019 included:

Revenues of approximately $6.8 million, an increase of $1.2 million or 27.7% compared to prior quarter;
Year to date revenue of approximately $12.2 million in 2019 compared to $11.9 million in 2018;
Increased focus on our highly profitable Canadian market representing 26% for the three months ended June 30, 2019 compared with 13% for the previous quarter;
Continued diversification of revenue streams with e-commerce business representing 23% of total revenues in the three months ended June 30, 2019 as compared to 7% of total revenues in the three months ended June 30, 2018;
Total operating loss of $1.2 million for the three months ended June 30, 2019 representing a 21% decrease from the previous first quarter 2019 results and from the three months ended June 30, 2018 results
Sales & marketing expense as a percentage of total revenue declined to 41.7% for the three months ended June 30, 2019 compared with 75.6% in comparable period in the prior year;
Quarterly product subscription and outbound concierge net revenue of $1.1 million compared to $0.7 million in the prior year or a 57.1% increase;
Cash used in operations of $0.8 million for the three months ended June 30, 2019 compared with $2.8 million in the comparable period in the prior year;
Reduced net loss per share to $0.66 for the three months ended June 30, 2019 compared with $0.94 for the comparable period in the prior year;
Company’s cash and merchant processor holdback position as of August 9, 2019 was $2.1 million; and
Expanded our FDA approved ANDA pipeline by three new OTC products.
2019 Second Quarter and Recent Corporate Progress

Established relationship with two large media publication organizations in Canada;
Announced supply relationship with a third party to supply Omeprazole 20mg tablets and Omeprazole 20mg 24 hour delayed release capsules approved by the FDA for the treatment of frequent heartburn;
Announced the CPNP notification number required to commercialize Diabasens in all 28 member countries of the European Union; and
Engaged with a third-party fulfillment company to support Canadian sales to reduce shipping costs by up to 45%.
"We continue to show improvements in our sales and marketing focused on achieving profitability as we spend on highly profitable sales channels and geographies, diversify our revenue streams and expand globally which has resulted in a reduction of our operating loss by 21% compared with the prior quarter. We continue to work on identifying cost efficiencies and profitable revenue streams to enhance our core business, increase our product revenues and work towards our goal of profitability," stated Bassam Damaj, President and Chief Executive Officer of Innovus Pharma.

The Company will host a conference call at 4:15 p.m. ET/1:15 p.m. PT today to discuss the financial results and recent business developments. To participate in the call, please dial 1-877-270-2148 for domestic callers or 1-412-902-6510 for international callers and request to join the Innovus Pharmaceuticals conference call. A replay of the call will be available for 30 days. To access the replay, dial 1-877-344-7529 domestically or 1-412-317-0088 internationally or 1-855-669-9658 for Canada and reference Replay Access Code: 10134333. The replay will be available shortly after the end of the conference call.

Altimmune Announces Second Quarter 2019 Financial Results and Provides a Business Update

On August 13, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the three and six months ended June 30, 2019 and provided a business update (Press release, Altimmune, AUG 13, 2019, View Source [SID1234538730]).

"2019 continues to be a transformative year for Altimmune, as we have met important strategic milestones through the acquisition of our NASH drug candidate, ALT-801, by successfully completing a pre-IND meeting with the FDA on HepTcell, and by obtaining encouraging data on NasoShield," said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "These milestones solidify our value proposition as a biotech company with a diversified product pipeline poised to address large unmet medical needs. We are keenly focused on advancing the development of our product candidates to achieve meaningful inflection points in the near future."

Recent Highlights

Acquisition of Spitfire Pharma, Inc. with NASH Candidate ALT-801
The Company acquired Spitfire Pharma, Inc. including the product candidate ALT-801, a potent GLP-1/Glucagon receptor dual agonist for the treatment of non-alcoholic steatohepatitis (NASH). ALT-801 is a peptide-based therapeutic candidate with balanced agonist activity on the GLP-1 and glucagon receptors and a differentiated PK profile. ALT-801 is designed to treat the underlying metabolic dysfunction that leads to NASH, the most severe form of non-alcoholic fatty liver disease (NAFLD), by acting upstream to block disease progression. The Company is preparing for an IND submission in 2020, with data readouts from a Phase 1 clinical trial anticipated during 2021.
HepTcell Successful Pre-IND Meeting with FDA
The Company successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its Phase 2 trial design and manufacturing plans for HepTcell. The FDA provided no objection to the planned study design and patient populations, or plans for manufacturing and product testing, and did not recommend any additional studies for an IND submission and initiation of Phase 2 trials. A recently completed Phase 1 study in chronically infected subjects was performed in the United Kingdom and South Korea where clear evidence of anti-HBV T cell activation in the highly immune-tolerized study population was noted. Altimmune intends to conduct a Phase 2 study in the United States in 2020 and the pre-IND meeting was held to obtain feedback from the FDA on the Company’s intended development path.
NasoShield Investigation Results Point Toward Improved Clinical Performance
An investigation into the lower than expected Phase 1 immunogenicity of NasoShield has provided compelling data that may resolve the disparate results obtained from the previous preclinical and clinical studies with the intranasal anthrax vaccine. The key finding was that induction of rapid and robust immunity was significantly impacted by the dosing position. In the investigation, nearly 80% of the vaccinated animals survived a lethal challenge when dosed in the standard supine position, compared to 0% survival following dose administration in a sitting position similar to the dosing position used in the Phase 1 study. Based on these results, the Company believes that a simple adjustment to the dosing position in humans will result in significantly higher immunogenicity similar to what was observed during the preclinical development of NasoShield. The Company is in discussions with Biomedical Advanced Research and Development Authority ("BARDA") about next steps for the program. NasoShield is funded through a contract with BARDA (HHSO100201600008C) with a total potential value of $130 million if all options in the contact are exercised.
ALT-702 Preclinical Development Update
During Q2, the Company received a Notice of Allowance from the United States Patent and Trademark Office for patent application No. 15/968,839, entitled "Immunogenic Compound" related to its immunostimulant product candidate, ALT-702, which, when granted, will be the second issued patent for this product. This candidate is based on a new synthetic peptide conjugate technology platform and represents a new approach in immuno-oncology that can act alone or improve the effectiveness of immune checkpoint inhibitors, oncolytic viruses and other approaches in immuno-oncology. The Company is currently conducting experiments on ALT-702 in murine tumor models and expects to provide an update on the results of these experiments later this year.
Financial Results for the Second Quarter Ended June 30, 2019

The Company had cash, restricted cash and cash equivalents of $41.7 million at June 30, 2019. Subsequent to quarter end, the Company collected $1.5 million in accounts receivable from U.S. government contracts representing payment on outstanding invoices from Q2.

Revenue in the second quarter was $1.6 million compared to $2.4 million in the prior year period. The change was due to a decrease in billings under the Company’s U.S. government contracts due to timing of manufacturing and clinical trials.

Research and development expenses in the second quarter were $2.9 million compared to $4.9 million in the prior year period. The decrease was attributable to lower manufacturing and clinical trial costs on its programs offset by transaction costs recognized related to the acquisition of Spitfire Pharma, Inc.

General and administrative expenses in the second quarter were $2.2 million compared to $2.9 million in the prior year period. The decrease was due primarily to a reduction in labor, legal and professional costs.

Net loss attributed to common stockholders for the second quarter was $3.4 million, or ($0.26) per share, compared to $9.8 million, or ($10.29) per share in the same period of 2018. The lower net loss is attributable to a $5.2 million charge related to the warrant liability in 2018, in addition to the changes in revenue, research and development expense, and general and administrative expense described above.
Conference Call Details
Date: Wednesday, August 14, 2019
Time: 8:30am Eastern Time
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13692577
Webcast: View Source
Following the conclusion of the call, the webcast will be available for replay for 30 days on the Investor Relations page of the Company’s website at www.altimmune.com.